Browse Device Recalls
478 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 478 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 478 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | 10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Pro... | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1 | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Jan 15, 2020 | Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Cathe... | There is the potential for various failures with the LOR (loss of resistance) syringes included i... | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE COMPONENT AN-05505 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow¿ EPIDURAL CATHETERIZATION KIT AK-05000 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT JH-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL NEEDLE KIT SL-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow SPINAL ANESTHESIA SET ASA-25090-S | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT AM-05500 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Maximal Barrier Drape ASK-00002-1A | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ S... | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT CK-02220 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow EPIDURAL CATHETERIZATION KIT YC-02220 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow Central Venous Catheterization Kit ASK-04200-UPM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | PICC Set- PR-35052-HPHNM | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 20, 2019 | Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1 | Product lidstock contains the incorrect expiration date for the product | Class II | Arrow International Inc |
| Dec 12, 2019 | Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane ove... | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instea... | Class II | Arrow International Inc |
| Dec 6, 2019 | Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH | Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Ca... | Class II | Arrow International Inc |
| Nov 15, 2019 | Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 | Potential leak in the balloon extension line. If a leak was present and went undetected during pr... | Class II | Arrow International Inc |
| Nov 15, 2019 | Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J | Potential leak in the balloon extension line. If a leak was present and went undetected during pr... | Class II | Arrow International Inc |
| Aug 6, 2019 | Arrow 8.5 Fr. X 16 cm Quad-Lumen Central Venous Catheterization Kit Product ... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Aug 6, 2019 | 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Cat... | Products may contain the incorrect banner card within the kit | Class II | Arrow International Inc |
| Jul 18, 2019 | Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circ... | Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm ... | Class II | Arrow International Inc |
| May 17, 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARR... | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (... | Class II | Arrow International Inc |
| Apr 23, 2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A | Lidstock states the incorrect expiration date for the product | Class II | Arrow International 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.