Browse Device Recalls
929 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 929 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 929 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 20, 2022 | regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery conve... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery c... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 | Specific lots of FLXfit implants have internal components that may have been manufactured using s... | Class II | CoreLink LLC |
| Oct 20, 2022 | regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; orth... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho sur... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery c... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery conveni... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 83009900... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 12, 2022 | BASIN SET, MEBS42K, general surgical kit | Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the... | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various PICC Line, Central Line Packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various Laparoscopy Packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various hysterectomy, vaginal packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various Cysto Packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various Angiography/Cath Lab packs/trays | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various ENT Packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various Pacemaker Packs, Cardio Thoracic Packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various neurology packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various eye packs, cataract packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various ob/gyn packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various Port Insertion Packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | D&C pack | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various convenience packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various convenience packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various C-section packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Breast Abdominoplasty Pack | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 16, 2022 | Various Angiography packs/trays | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Class II | American Contract Systems, Inc. |
| Jun 3, 2022 | Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | Class II | ROi CPS LLC |
| Jun 3, 2022 | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part ... | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | Class II | ROi CPS LLC |
| May 20, 2022 | regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. | A nonsterile component was packaged in a sterile convenience kit. | Class II | ROi CPS LLC |
| May 3, 2022 | regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003 | Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. | Class II | ROi CPS LLC |
| May 3, 2022 | Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. ... | Potential for the tip of the electrode to detach during use. | Class II | ROi CPS LLC |
| May 2, 2022 | Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID ... | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| May 2, 2022 | Clean Catch Urine Kit NS 178489, AHMU58A | Affected products were assembled off-site by individuals who may not have been properly trained. | Class I | American Contract Systems, Inc. |
| Apr 5, 2022 | The following first aid kits and cabinets containing components Medi-First XS... | First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at... | Class II | Certified Safety Mfg Inc |
| Mar 22, 2022 | ACS IR - Angio Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.