Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4751–4775 of 5111

CriticalFDA (Devices)·Z-2126-2013·2013-09-18
Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2123-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall
Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.
Product
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacte
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2125-2013·2013-09-18
Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Product
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gra
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2124-2013·2013-09-18
Siemens Microscan Plus Negative Combo 3 Recalled for Misreads
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Product
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2182-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
Product
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2181-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
Product
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2186-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
The FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing a
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2185-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA Class II recall of Monoject 100 Units/mL Heparin Lock Flush syringes due to potential non-sterile water contamination.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2180-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
Covidien LLC is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1993-2013·2013-09-18
Cardiogenesis Transmyocardial Laser Recalled Due to Sparks and Burns
Cardiogenesis Corporation is recalling 2,498 Transmyocardial Laser devices due to reports of sparks, burns, or smoke incidents.
Product
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atheros
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2179-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
FDA is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2184-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination
FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water. The products are distributed in the USA and Bermuda.
Product
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2120-2013·2013-09-18
Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
Product
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2178-2013·2013-09-18
Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination
The FDA is recalling Monoject flush syringes that may contain non-sterile water instead of saline or heparin, posing a risk of infection.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2067-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2097-2013·2013-09-04
Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach
Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.
Product
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is
Category
Medical Device
Distribution
11 states
SevereFDA (Devices)·Z-2077-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2055-2013·2013-09-04
Zimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor
Zimmer, Inc. is recalling 771 units of the Trabecular Metal Reverse Shoulder Glenosphere Distractor due to potential mechanical failure if used without proper lubrication.
Product
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2130-2013·2013-09-04
Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks
Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.
Product
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. N
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1976-2013·2013-08-28
Stryker Oasys Midline Occiput Plate Recalled for Post-Operative Pin Fracture
Stryker Spine is recalling Oasys Midline Occiput Plates because customer reports indicate post-operative fracture of the pin connecting the tulip head to the plate body.
Product
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2042-2013·2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Ster
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1982-2013·2013-08-28
EndoGastric Solutions Recalls EsophyX2 Devices Due to Tissue Mold Control Loss
EndoGastric Solutions is recalling EsophyX2 devices because of reports of loss of tissue mold control, which required surgical removal in one case.
Product
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2039-2013·2013-08-28
Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 0059
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2028-2013·2013-08-28
Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations.
Product
00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1899-2013·2013-08-21
Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.
Product
Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
Category
Medical Device
Distribution
Distributed nationwide

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