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3 catalogue numbers from IPN929596, listed by Teleflex Medical LLC, United States, under Laryngoscope, Rigid. 44 manufacturers in China are registered for this product code.
44manufacturers in China registered for this device type
3catalogue numbers in this listing
16recalls on this code
Who Else Makes It
Concentrated in Guangdong (22), Jiangsu (9), Zhejiang (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 44. All 44 manufacturers in China registered for Laryngoscope, Rigid
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | CCW |
| Device type | Laryngoscope, Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-05-13 |
| Record revised | 2026-02-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN929596 | In distribution | |
| IPN929610 | In distribution | |
| IPN929611 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 509 |
| SunMed | SunMed Group Holdings, LLC | 255 |
| Ambler Surgical | Ambler Surgical, LLC | 192 |
| AincA® | Anesthesia Associates, Inc. | 186 |
| Curaplex | Bound Tree Medical, LLC | 172 |
| GlideScope® | Verathon Medical (Canada) ULC | 166 |
| Pilling | Teleflex Medical LLC | 163 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 157 |
| Laryngoscope, Rigid | Karl Storz GmbH & Co. KG | 140 |
| Medline | Medline Industries, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 111 |
| Sklar® | Sklar Corporation | 92 |
Showing 12 of 442. All products under Laryngoscope, Rigid
Recalls
14 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 | Closed |
|---|---|---|---|---|---|
| 2021-02-18 | Class II | Under Investigation by firm | Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge. | 157, 150 units (156,980 units in the US; 170 units OUS) | 2026-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 350779 units | 2023-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 29740 units | 2023-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 75320 units | 2023-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 7401 units | 2023-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 27341 units | 2023-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 301085 units | 2023-08-31 |
| 2020-07-06 | Class II | Process control | Breaking at the point of a welded joint | 20600 units | 2023-08-31 |
| 2020-01-09 | Class II | Process control | The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient’s mouth. | 338,928 (199,018 US and 139,910 OUS) for all products | 2023-09-11 |
| 2020-01-09 | Class II | Process control | The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient’s mouth. | 338,928 (199,018 US and 139,910 OUS) for all products | 2023-09-11 |
| 2017-01-10 | Class II | Package design/selection | The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2. | 2140 units | 2021-04-13 |
| 2014-07-09 | Class II | Other | Packaging Error: Customers have reported receiving incorrect product. The box labeling indicates the correct product MAC 4 but the contents are incorrect, Miller 4 blades. | 120 units | 2015-11-09 |
| 2014-06-30 | Class II | Device Design | There is a possibility the handle of the laryngoscope may heat up and melt the end cap. | 6,246 units | 2017-03-21 |
| 2013-10-15 | Class II | Other | Labeling inconsistency | 6,200 ea. | 2015-11-04 |
| 2007-03-01 | Not classified | Nonconforming Material/Component | The MRI Battery is out of specification for its magnetic content. | 1 kit | 2007-05-03 |
| 2006-06-15 | Not classified | Component change control | Teleflex Medical has identified that the product may malfunction, causing the handle to heat up. There is a potential for the heated handle to burn the user. | 1,408 laryngoscopes | 2009-08-28 |
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.