ACS
ASC/MOR Ortho LG Table SET-UP (PS 94408)
1manufacturer
3,812catalogue numbers in this listing
40recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-12-12 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2021-12-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IHTS95AB | In distribution | |
| CCKA38E | In distribution | |
| EFHD60A | In distribution | |
| SFSA51E | In distribution | |
| UIHN18AL | In distribution | |
| FITJ01U | In distribution | |
| MDRK10G | In distribution | |
| FHAC62P | In distribution | |
| BHLE58H | In distribution | |
| MKMA57J | In distribution | |
| UTTH37Z | In distribution | |
| CCHL29D | In distribution | |
| HSPH40H | In distribution | |
| FDPD04AB | In distribution | |
| UIKN28AM | In distribution | |
| UIKD55G | In distribution | |
| MMTK66D | In distribution | |
| FTTK01O | In distribution | |
| PWHP43P | In distribution | |
| IASH65A | In distribution | |
| RCTK85B | In distribution | |
| CSKN20D | In distribution | |
| BDPD87B | In distribution | |
| FAUE10AI | In distribution | |
| CCHG48C | In distribution | |
| MCHA11H | In distribution | |
| AHAC46B | In distribution | |
| HSTO01L | In distribution | |
| UDKN68Z | In distribution | |
| AHOR32S | In distribution | |
| PLSH91H | In distribution | |
| PREM38F | In distribution | |
| EVHD34A | In distribution | |
| VETK65Q | In distribution | |
| LSRSHARC | In distribution | |
| PLAR83G | In distribution | |
| UDIH90O | In distribution | |
| UTTK33AG | In distribution | |
| IAHD53C | In distribution | |
| ALAR47F | In distribution | |
| PCAR16E | In distribution | |
| CHHF60E | In distribution | |
| FHHP63W | In distribution | |
| WLTJ14A | In distribution | |
| FHSH28AG | In distribution | |
| AVSA12A | In distribution | |
| CCVS47F | In distribution | |
| SFEX02D | In distribution | |
| UIOT55V | In distribution | |
| ESPD64B | In distribution | |
| HSFT76Q | In distribution | |
| CGPD52B | In distribution | |
| RTAT32E | In distribution | |
| CCKN16D | In distribution | |
| THEX27A | In distribution | |
| IHTS95AC | In distribution | |
| LMSN44AC | In distribution | |
| GRTS90F | In distribution | |
| FTPO51J | In distribution | |
| SPAH48L | In distribution | |
| FOAR08G | In distribution | |
| IHAR39Z | In distribution | |
| MRHB12N | In distribution | |
| UIHA20M | In distribution | |
| FDTH08AF | In distribution | |
| HUKN04A | In distribution | |
| LKSH77Q | In distribution | |
| BHOT29E | In distribution | |
| ANBO55Z | In distribution | |
| TNFA40J | In distribution | |
| AHEX75D | In distribution | |
| UISH14AA | In distribution | |
| AUAR11C | In distribution | |
| SPTH50AE | In distribution | |
| NEHI26B | In distribution | |
| HHLE11D | In distribution | |
| ACTK56B | In distribution | |
| FRTH63U | In distribution | |
| SFSA52A | In distribution | |
| FOTJ09M | In distribution | |
| NCTH24K | In distribution | |
| FTHD18J | In distribution | |
| UIHA20L | In distribution | |
| FTTH04I | In distribution | |
| ANTH64AH | In distribution | |
| FIKS12F | In distribution | |
| UDKN68AH | In distribution | |
| SLAR52C | In distribution | |
| MKMA57H | In distribution | |
| AUSH42F | In distribution | |
| FHTK32AC | In distribution | |
| UHTK60AH | In distribution | |
| SATO27F | In distribution | |
| HWOR77G | In distribution | |
| EVSH23D | In distribution | |
| HSFT76N | In distribution | |
| FHTH18AM | In distribution | |
| UIHA20J | In distribution | |
| BLKN16H | In distribution | |
| SFSH59T | In distribution | |
| RWVT48J | In distribution | |
| UITK97L | In distribution | |
| BLHP10G | In distribution | |
| GUKN13D | In distribution | |
| PCEX64E | In distribution | |
| THSH07A | In distribution | |
| HHTK38E | In distribution | |
| LSRHUMTOTPKD | In distribution | |
| LKTH15V | In distribution | |
| MMHP45B | In distribution | |
| LLTK28E | In distribution | |
| UIHP11D | In distribution | |
| RWTK14G | In distribution | |
| FTTK01P | In distribution | |
| MDRH11C | In distribution | |
| MKTK08I | In distribution | |
| LMLE46W | In distribution | |
| UDHP87AD | In distribution | |
| ANBO55AC | In distribution | |
| IHTK48AL | In distribution | |
| MMUE31D | In distribution | |
| BRME20X | In distribution | |
| TNAR22U | In distribution | |
| UITK33AD | In distribution | |
| LMSP15AF | In distribution | |
| CCTH41C | In distribution | |
| ISOS90G | In distribution | |
| SCSP40F | In distribution | |
| FLOR01K | In distribution | |
| BUSH84H | In distribution | |
| CBKA30E | In distribution | |
| MMKS15E | In distribution | |
| SFTK54B | In distribution | |
| UIHN18AC | In distribution | |
| BPKA49C | In distribution | |
| FAUE10AD | In distribution | |
| CIAR72I | In distribution | |
| UIOS80W | In distribution | |
| RBTB19M | In distribution | |
| HSPO50N | In distribution | |
| MPCH20H | In distribution | |
| CLKS91H | In distribution | |
| RGSA07L | In distribution | |
| BPKN15A | In distribution | |
| MHTH90AF | In distribution | |
| HSTH03O | In distribution | |
| WETK11E | In distribution | |
| OSTH66E | In distribution | |
| NERE41F | In distribution | |
| CMOR73AA | In distribution | |
| AMAR29V | In distribution | |
| UDHN97Y | In distribution | |
| ACAR61B | In distribution | |
| MCTJ74B | In distribution | |
| CNAR77G | In distribution | |
| SLUE07F | In distribution | |
| MDAR06G | In distribution | |
| AHEX25M | In distribution | |
| HSFA88A | In distribution | |
| MEOR10Q | In distribution | |
| BHLE58F | In distribution | |
| ISTH09F | In distribution | |
| ISTK11G | In distribution | |
| COTK42K | In distribution | |
| IHTH46AM | In distribution | |
| ESPD64C | In distribution | |
| HSHK33B | In distribution | |
| LMHU47U | In distribution | |
| PCHD28D | In distribution | |
| FALE76V | In distribution | |
| SMTH06N | In distribution | |
| PWTK04Y | In distribution | |
| UDHP87X | In distribution | |
| CCKP13E | In distribution | |
| FITJ01Q | In distribution | |
| HSHI92K | In distribution | |
| FDKA44O | In distribution | |
| CXVT24D | In distribution | |
| MEEX01O | In distribution | |
| HSOR99I | In distribution | |
| BPKB46A | In distribution | |
| HCSP23H | In distribution | |
| MDRH11F | In distribution | |
| EMHP84E | In distribution | |
| CGPD52D | In distribution | |
| ISAR20F | In distribution | |
| LKTH15W | In distribution | |
| UICA66AP | In distribution | |
| PWAR90I | In distribution | |
| RTSP44G | In distribution | |
| MRSP16M | In distribution | |
| SCAR03V | In distribution | |
| CFTO28G | In distribution | |
| LLEX34G | In distribution | |
| BPHD16B | In distribution | |
| DRKA13A | In distribution | |
| TNAR22X | In distribution | |
| HKTK61E | In distribution | |
| SMSA45L | In distribution | |
| LKTH15P | In distribution | |
| UITH88AF | In distribution | |
| LKSH77N | In distribution | |
| MPTJ16L | In distribution | |
| MITK85A | In distribution | |
| MPCH20D | In distribution | |
| RTTJ01B | In distribution | |
| OSLE44E | In distribution | |
| IHAR39AC | In distribution | |
| FOPP04I | In distribution | |
| WVEX16F | In distribution | |
| LMTK17AR | In distribution | |
| FTPO51K | In distribution | |
| NWSP44G | In distribution | |
| CASH15A | In distribution | |
| WHTH01B | In distribution | |
| HOOR27D | In distribution | |
| MWAH32P | In distribution | |
| UITH88AH | In distribution | |
| NEBE48D | In distribution | |
| CMDH12M | In distribution | |
| MMSH31E | In distribution | |
| FIKS12D | In distribution | |
| BBHP10C | In distribution | |
| UIAA53AF | In distribution | |
| LEMO55A | In distribution | |
| HNTH76M | In distribution | |
| OWTK40N | In distribution | |
| LMAR60C | In distribution | |
| SETH15G | In distribution | |
| MREX02L | In distribution | |
| WHKN46G | In distribution | |
| WXSA12H | In distribution | |
| AHOR31R | In distribution | |
| FRBK74X | In distribution | |
| WVTK18I | In distribution | |
| SLUE97B | In distribution | |
| BFTK01Y | In distribution | |
| CCKA38B | In distribution | |
| FTTK01Q | In distribution | |
| CHHF60G | In distribution | |
| FDKA44K | In distribution | |
| HSPH40Q | In distribution | |
| AMTH02AD | In distribution | |
| NEKA61D | In distribution | |
| MMTJ06M | In distribution | |
| MITK00B | In distribution | |
| CETK36H | In distribution | |
| LMEX53H | In distribution | |
| PCTS17C | In distribution | |
| JSLE08D | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
| Sapphire | Spinal Elements, Inc. | 76 |
Showing 12 of 367. All products under Orthopedic Tray
Recalls Naming This Product
51 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| American Contract Systems, Inc. | UDI-DI | 2025-09-04 | Class II | Nonconforming Material/Component | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycle | 32,433 total |
| American Contract Systems, Inc. | UDI-DI | 2025-07-14 | Class II | Under Investigation by firm | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS | 588 units |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 388 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 24 kits |
| American Contract Systems, Inc. | UDI-DI | 2024-08-07 | Class II | Under Investigation by firm | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | 48 units |
| American Contract Systems, Inc. | UDI-DI | 2024-08-07 | Class II | Under Investigation by firm | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | 12 units |
| American Contract Systems, Inc. | UDI-DI | 2024-08-07 | Class II | Under Investigation by firm | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | 60 units |
| American Contract Systems, Inc. | UDI-DI | 2024-08-07 | Class II | Under Investigation by firm | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. | 2 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 345 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 66 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 26 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 48 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 50 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 96 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 272 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 129 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 84 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 552 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 107 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 48 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 36 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 192 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 8 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 272 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 84 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 36 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 50 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 26 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 36 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 24 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 24 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 270 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 976 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 352 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 28 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 85 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 27 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 27 units |
| American Contract Systems, Inc. | UDI-DI | 2024-05-15 | Class II | Under Investigation by firm | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. | 393 units |
Showing 40 of 51.
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-05-19 | Class II | Nonconforming Material/Component | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin le | 160 kits |
| 2025-04-21 | Class II | Finished device change control | Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay | 850 Kits |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.